MAUDE Adverse Event Report: FOOTPRINT MEDICAL INC. POLYURETHANE, SINGLE LUMEN 1.4FR (Ø 0.47 MM) X 30 CM LENGTH; PICC

Model Number	P1PIC1.4-C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/04/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the peripherally inserted central catheter (part p1pic1.4-c, lot 210456) was removed from the patient on (b)(6) 2022.At the time of removal, the catheter was documented to have been removed in total, however, an x-ray performed on (b)(6) 2022 revealed a 6cm portion of a catheter remained in the patient.Surgical removal of the remaining portion was performed on (b)(6) 2022.During the procedure, 5cm of a 6cm length was removed, leaving 1cm in the patient.
Additional Manufacturer Narrative
Investigation included reviewing device history records and information from the user facility.The investigation indicated no evidence of manufacturing related issues that could have contributed to the event.

• Brand Name: POLYURETHANE, SINGLE LUMEN 1.4FR (Ø 0.47 MM) X 30 CM LENGTH
• Common Device Name: PICC
• Manufacturer (Section D): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer (Section G): FOOTPRINT MEDICAL INC.; 5823 sebastian place; san antonio TX 78249
• Manufacturer Contact: robert davis ; 5823 sebastian place; san antonio, TX 78249 ; 2102262600
• MDR Report Key: 14886368
• Report Number: 3007697249-2022-00002
• Device Sequence Number: 14718066
• Product Code: LJS
• UDI-Device Identifier: 00858778006058
• UDI-Public: (01)00858778006058(17)230521(10)210456
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K130507
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2023
• Device Model Number: P1PIC1.4-C
• Device Lot Number: 210456
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/01/2022
• Initial Report FDA Received Date: 07/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown